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Check a medical device's FDA status

Buying or selling used equipment? Work through these six checks with the device or its label in front of you. They use the FDA's free public databases, and you can run two of the searches right here.

Six steps Last checked against FDA sources

  1. Identify the device

    Every FDA record is filed under a maker, a device name, and a product code, so start with the exact names on the device.

    • Write down the manufacturer and model exactly as the label shows them, with any model or catalog number.
    • Look for a UDI, the Unique Device Identifier: a barcode with a printed number on the label or the device. Newer devices carry one; older equipment may not. Enter it at AccessGUDID to see the device's FDA product code and premarket number.
    • Note whether the label says "Rx only". It decides who the device can be sold to (step 6).

    Open AccessGUDID

  2. Find its classification

    The FDA sorts devices into three classes by risk, and the class decides what the device needed before it could be sold.

    Class I
    Lowest risk. About three in four Class I device types are exempt from the 510(k).
    Class II
    Moderate risk. Most need a 510(k) clearance; some are exempt.
    Class III
    Highest risk. Generally needs premarket approval (PMA).

    Open a code's FDA record to see its submission type and whether it is exempt.

    Open FDA's classification database

  3. Find its marketing authorization

    Unless it is exempt, a device reaches the US market by one of three routes, and each leaves a public record with its own number.

    510(k)
    Cleared. Shown to be substantially equivalent to a device already on the market. Number starts with K.
    De Novo
    Granted. A new kind of lower-risk device with nothing to compare it to. Number starts with DEN.
    PMA
    Approved. The route for most Class III devices. Number starts with P.
    Exempt
    No premarket submission. The maker still has to register and list the device (step 5).

    176,415 FDA 510(k) decisions since 1976, through October 11, 2026, updated weekly. A clearance covers the device and intended use it names; a modified device or a new intended use can need a new 510(k). If the device needed a clearance or approval and you can't find one, ask the seller for the number.

    FDA 510(k) database De Novo database PMA database

  4. Check for recalls

    A recall can mean the unit needs a correction from its manufacturer before it is used.

    • Search FDA's recall database by device name or manufacturer. It covers recalls the FDA has classified since November 2002.
    • Open any match and compare the model and the lot or serial numbers in the notice with the unit.
    • If the model was recalled, ask the seller whether the correction was done on this unit, and for its service records.

    Open FDA's recall database

  5. Check registration and listing

    Device manufacturers register their facilities with the FDA every year and list the devices they make.

    • Search FDA's Establishment Registration and Device Listing database for the manufacturer.
    • Check that the device is listed under the product code you found in step 2.

    There is no such thing as an FDA certificate. The FDA does not issue registration certificates, and a registration does not mean a device is approved or cleared. If a seller offers a certificate as proof, check the databases instead.

    Open FDA's registration and listing database

  6. Know the rules for dealers, and keep a record

    What you have to do depends on what you do to the equipment.

    Reselling or refurbishing
    Refurbishers and remarketers of used devices already sold in the US do not register, list, or pay the FDA fee.
    Remanufacturing
    Work that significantly changes a device's performance, safety specifications, or intended use makes you its manufacturer, with registration, listing, quality system, and reporting duties. Servicing, which returns a device to its original specifications, does not. FDA's 2024 guidance explains the difference.
    Importing
    The initial importer of a device must register with the FDA and have a US address.
    Prescription devices
    A device labeled "Rx only" may be sold only to, or on the order of, a licensed practitioner.
    State rules
    Your state may have its own requirements for selling medical devices, so check them too.